壮药制剂武打将军酊质量标准研究

Study on Quality Standards of Wudajiangjun Tincture

【目的】为确保壮药制剂武打将军酊临床用药安全有效，建立其质量标准。【方法】采用薄层色谱法对武打将军酊处方中的虎杖、莪术、川芎、徐长卿、龙血竭、薄荷脑等药材进行定性鉴别；采用高效液相色谱法对酊剂中的虎杖苷、丹皮酚有效成分进行含量测定。【结果】建立上述6味药材的薄层色谱鉴别法，色谱图特征斑点分离清晰、集中。高效液相色谱法中虎杖苷对照品进样量在0．1～O．7μg时，进样量与峰面积呈良好的线性关系；丹皮酚对照品进样量在0．052～O．364μg时，进样量与峰面积呈良好的线性关系；虎杖苷平均回收率为100．98％，RSD=1．O9％；丹皮酚平均回收率为99．62％，RSD=0．91％。【结论】本文建立的武打将军酊质量标准可有效控制壮药制剂武打将军酊的质量。

【Objective】The quality standards for Wudajiangjun Tincture were established in order to guarantee its safety and effectivity in clinical treatment.【Methods】Thin layer chromatograms(TLC)method was used for qualitative identification of extracts from the tincture,including giant knotweed rhizome,zedoray rhizome,sichuan lovage rhizome,paniculate swallowwort root,Resina draconis,mentha-camphor and other medicinal materials qualitative.High performance liquid chromatography(HPLC)method was used to quantitatively determine active ingredients of the tincture such as polydatin and paeonol.【Results】Characteristics of TLC spots for the abovementioned 6medicinal materials were clear separation and concentrated.In HPLC method,agood linear relationship between sample content and peak area was received when the reference substance of polydatin was ranged from 0.1to 0.7μg,and when paeonol concentration was within the range of 0.052 to 0.364μg.【Conclusion】The scientific quality standards of Wudajiangjun Tincture are successfully established,which can be used to effectively control the product quality for Zhuang medicine preparations of Wudajiangjun Tincture.